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NCT Number: NCT03904121

Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival.

Patients aged > 80 years represent an increasing proportion of colon cancer diagnoses. It is important to have relevant and trustable data concerning elderly colorectal cancer patients surgery and postoperative morbidity, functional ability, life quality and survival numbers. With possibly compromised health status and functional decline the benefits of surgical management and outcomes can diminish life quality and overall survival.

With proper patients selection, preoperative health evaluation and thus patient information, colorectal cancer surgery can be performed with lower morbidity and mortality rates with comparative survival numbers.

The aim of this prospectively collected, observational study is to acquire data from colorectal cancer surgery in aged over 80 years and perform statistical analysis of the preoperative risk factors affecting postoperative morbidity, functional recovery, mortality and overall survival.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University

Tampere, 33100, Finland

About this study

9 Finnish hospitals including three university hospitals participate in the study. The data is collected from the hospitals using a specially designed and secure web application (RedCap).

The preoperative patients' data include comorbidities, clinical frailty scale (CFS) and functional status, postoperative surgical and medical outcomes and survival data. The patient questionnaire is based on the G-8 geriatric screening tool and MNA-short form. The questionnaire is filled out preoperatively and 1, 3, 6 and 12 months postoperatively. The patient data concerning procedures is collected from the hospitals prospectively recording data. Mortality data on causes of death are obtained from Statistics Finland.

All colon cancer patients aged over 80 years with curative disease (stage I-III) are included. Patients with metastatic disease or severe Alzheimer disease are excluded. They are treated either non-operatively or with curative resection or palliative procedure. Patients fill out the approval form. The study is acknowledged by the ethics committee of the participating hospitals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary colon cancer, which is surgically treated with curative intent (stage I-III)

Exclusion criteria

  • metastatic colon cancer, severe dementia, life expectancy less than six months

Treatment and study plan

Curative operation

Procedure

Postoperative morbidity, mortality, functional outcome, survival

Other names: Palliative operation, Non-operative treatment

Primary outcomes

  1. Postoperative morbidity

    Time frame: 30 days

    Clavien-Dindo classification (0-V)

  2. Postoperative mortality

    Time frame: 12 months

    Date of death

Secondary outcomes

  1. Functional performance

    Time frame: 12 months

    Patient questionnaire ( nutritional status, mobility, use of implements, medication, weight, housing, homeaid), scale 0-3; 0= no, 1= sometimes, 2= often, 3= always

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 4, 2019
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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